Clinical Events After Deferral of LAD Revascularization Following Physiological Coronary Assessment.

BACKGROUND: Physicians are not always comfortable deferring treatment of a stenosis in the left anterior descending (LAD) artery because of the perception that there is a high risk of major adverse cardiac events (MACE). The authors describe, using the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) trial, MACE rates when LAD lesions are deferred, guided by physiological assessment using fractional flow reserve (FFR) or the instantaneous wave-free ratio (iFR). OBJECTIVES: The purpose of this study was to establish the safety of deferring treatment in the LAD using FFR or iFR within the DEFINE-FLAIR trial. METHODS: MACE rates at 1 year were compared between groups (iFR and FFR) in patients whose physiological assessment led to LAD lesions being deferred. MACE was defined as a composite of cardiovascular death, myocardial infarction (MI), and unplanned revascularization at 1 year. Patients, and staff performing follow-up, were blinded to whether the decision was made with FFR or iFR. Outcomes were adjusted for age and sex. RESULTS: A total of 872 patients had lesions deferred in the LAD (421 guided by FFR, 451 guided by iFR). The event rate with iFR was significantly lower than with FFR (2.44% vs. 5.26%; adjusted HR: 0.46; 95% confidence interval [CI]: 0.22 to 0.95; p = 0.04). This was driven by significantly lower unplanned revascularization with iFR and numerically lower MI (unplanned revascularization: 2.22% iFR vs. 4.99% FFR; adjusted HR: 0.44; 95% CI: 0.21 to 0.93; p = 0.03; MI: 0.44% iFR vs. 2.14% FFR; adjusted HR: 0.23; 95% CI: 0.05 to 1.07; p = 0.06). CONCLUSIONS: iFR-guided deferral appears to be safe for patients with LAD lesions. Patients in whom iFR-guided deferral was performed had statistically significantly lower event rates than those with FFR-guided deferral.

Diagnostic performance and cost of CT angiography versus stress ECG--a randomized prospective study of suspected acute coronary syndrome chest pain in the emergency department (CT-COMPARE).

BACKGROUND: Coronary CT angiography (CCTA) has high sensitivity, with 3 recent randomized trials favorably comparing CCTA to standard-of-care. Comparison to exercise stress ECG (ExECG), the most available and least expensive standard-of-care worldwide, has not been systematically tested. METHODS: CT-COMPARE was a randomized, single-center trial of low-intermediate risk chest pain subjects undergoing CCTA or ExECG after the first negative troponin. From March 2010 to April 2011, 562 patients randomized to either dual-source CCTA (n=322) or ExECG (n=240). Primary endpoints were diagnostic performance for ACS, and hospital cost at 30 days. Secondary endpoints were time-to-discharge, admission rates, and downstream resource utilization. RESULTS: ACS occurred in 24 (4%) patients. ExECG had 213 negative studies and 27 (26%) positive studies for ACS with sensitivity of 83% [95% CI: 36, 99.6%], specificity of 91% [CI: 86, 94%], and ROC AUC of 0.87 [CI: 0.70, 1]. CCTA (>50% stenosis considered positive) had 288 negative studies and 18/35 (51%) positive studies with a sensitivity of 100% [CI: 81.5, 100], specificity of 94% [CI: 91.2, 96.7%], and ROC of 0.97 [CI: 0.92, 1.0; p=0.2]. Despite CCTA having higher odds of downstream testing (OR 2.0), 30 day per-patient cost was significantly lower for CCTA ($2193 vs $2704, p<0.001). Length of stay for CCTA was significantly reduced (13.5h [95% CI: 11.2-15.7], ExECG 19.7h [95% CI: 17.4-22.1], p<0.0005), which drove the reduction in cost. No patient had post-discharge cardiovascular events at 30 days. CONCLUSIONS: CCTA had improved diagnostic performance compared to ExECG, combined with 35% relative reduction in length-of-stay, and 20% reduction in hospital costs. These data lend further evidence that CCTA is useful as a first line assessment in emergency department chest pain.

Improving the quality of percutaneous revascularisation in patients with multivessel disease in Australia: cost-effectiveness, public health implications, and budget impact of FFR-guided PCI.

PURPOSE: The international multicentre FAME Study (n=1,005) demonstrated significant health benefits for patients undergoing multivessel percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) measurement compared with angiography guidance alone (ANGIO). We determined the cost-effectiveness and the public health/budget impact for Australia. METHODS: We performed a prospective economic evaluation comparing FFR vs. ANGIO in patients with multivessel disease based on original patient-level FAME data. We used Australian utilities (EQ-5D) and costs to calculate quality-adjusted life years (QALYs) and incremental cost-effectiveness adopting the societal perspective. The public health and budget impact from the payer's perspective was based on Australian PCI registries. Uncertainty was explored using deterministic sensitivity analyses and the bootstrap method (n=5,000 samples). RESULTS: The cost-effectiveness analysis showed that FFR was cost-saving and reduces costs by 1,776 AUD per patient during one year. Over a two-year time horizon, the public health impact ranged from 7.8 to 73.9 QALYs gained and the budget impact from 1.8 to 14.5 million AUD total cost savings. Sensitivity analyses demonstrated that FFR was cost-saving over a wide range of assumptions. CONCLUSIONS: FFR-guided PCI in patients with multivessel coronary disease substantially reduces cardiac events, improves QALYs and is cost-saving in the Australian health care system.

Using DynaCT for the assessment of ilio-femoral arterial calibre, calcification and tortuosity index in patients selected for trans-catheter aortic valve replacement.

Adequate vascular access for femoral trans-catheter aortic valve replacement is fundamental to the success of the procedure. Assessment of vascular calibre, tortuosity and calcification is performed by angiography and multi-slice computed tomography (MSCT). Can DynaCT provide the same information as MSCT? 15 Patients underwent MSCT, angiography and DynaCT. Vessel diameter measurements were taken in three positions of the left and right ilio-femoral arteries. Tortuosity was assessed using an index of the direct distance and the distance taken by the artery between two points. Calcification was assessed in MSCT and DynaCT using a simple scoring system. Concordance correlation coefficient of arterial calibre between angiography and MSCT was 0.96 (95 % CI 0.94-0.97). DynaCT and angiography was 0.94 (95 % CI 0.91-0.96) and Dyna CT and MSCT, 0.95 (95 % CI 0.92-0.97). Bland-Altman tests demonstrate a mean difference between the angiogram and the MSCT of 0.06 mm (+0.97, -1.42), angiogram and DynaCT, 0.13 mm, (+1.00, -0.87), DynaCT and MSCT, 0.2 mm, (+1.15, -0.76). Tortuosity comparisons gave a median tortuosity index for MSCT 1.29 and DynaCT 1.23 (p = 0.472). Calcification comparisons of MSCT and DynaCT using correlation coefficients demonstrate a correlation of 0.245 (p = 0.378). Effective radiation doses were: DynaCT; 3.63 ± 0.65 mSv and angiography; 0.57 ± 0.72 mSv, MSCT; 7.15 ± 2.58 mSv. DynaCT is equal to MSCT and angiography in assessing femoral artery calibre. Like MSCT, it can assess tortuosity and can produce 3D images but is inferior in the assessment of calcification.

CT angiography with cardiac MRI: non-invasive functional and anatomical assessment for the etiology in newly diagnosed heart failure.

Exclusion of ischemia is important in patients with newly diagnosed systolic heart failure (HF). We prospectively compared standard-of-care invasive catheter angiography (iCA) and echocardiography to a novel non-invasive strategy of both Coronary Computed Tomographic Angiography (CCTA) and Cardiovascular MRI (CMR) to determine the etiology of myocardial dysfunction Prospective data were collected from consecutive patients referred for iCA to investigate echocardiographically-confirmed new onset HF. CMR (1.5T GE) and dual source CCTA were performed within 2-7 days of iCA. Results were blinded and separately analyzed by expert readers. 426 coronary segments from 28 prospectively enrolled patients were analyzed by CCTA and quantitative iCA. The per-patient sensitivity and specificity of CCTA was 100% and 90%, respectively, negative predictive value (NPV) 100%, positive predictive value (PPV) 78%. Mean ejection fraction by CMR was 24%. Presence of ischemic-type LGE on CMR conferred a 67% sensitivity, 100% specificity, 90% NPV and 100% PPV. Combining CCTA with CMR conferred 100% specificity, 100% sensitivity, 100% PPV and 100% NPV for detection or exclusion of coronary disease. In patients with negative CCTA all invasive angiograms could have been avoided. In addition, two patients with no ischemic LGE by CMR had severe coronary disease on both CCTA and iCA, indicating global hibernation. This is a noteworthy finding in contrast to previous reports which suggested that absence of LGE rules out significant CAD. CCTA with CMR in newly-diagnosed HF enables non-invasive assessment of coronary artery disease, the severity and etiology of myocardial dysfunction and defines suitability for revascularization. Absence of ischemic-type LGE at CMR does not exclude CAD as a cause of LV dysfunction. A first-line strategy of functional and anatomic imaging with CMR and CCTA appears appropriate in newly diagnosed HF.

Establishment of an innovative specialist cardiac indigenous outreach service in rural and remote Queensland.

Cardiovascular diseases are the leading cause of mortality in Indigenous Australians. Indigneous Australians present at a younger age and have a greater incidence of cardiac risk including smoking and diabetes than non-Indigenous Australians. Access to specialist health services is an important determinant of health care outcomes for these patients. We describe an innovative and successful for model for providing Outreach Cardiac Specialist services to Indigenous communities in rural and remote locations. The approach involves a step-wise process of a) community engagement, b) delivering recovery interventions to improve health outcomes, c) building community capacity to self manage chronic illness and promoting health and well being with the aim of d) community self governance of chronic disease and health promotion. Key elements to this process are community participation in the program, disease self-management led by local health care workers, open access that is all-inclusive utilising community-generated referral, and the translation of scientific knowledge of disease processes into community understanding and making culturally relevant connections. Specialist cardiac services and point of care diagnostics have been provided to 18 sites across rural and remote Queensland. More than 1400 episodes of care have been provided to Indigenous Australians with rheumatic heart disease, ischaemic heart disease and congenital heart conditions. Traditional values can work harmoniously with an inclusive medical approach in this relational model.

The value of dual-source 64-slice CT coronary angiography in the assessment of patients presenting to an acute chest pain service.

BACKGROUND: The absence of radiological evidence of plaque on computed tomographic coronary angiography (CTCA) reliably excludes obstructive coronary artery disease. METHODS: We studied patients who presented to our emergency department with chest pain and were admitted to our chest pain assessment service. If they were free of pain and without high-risk features of myocardial ischaemia including elevation of serum biomarkers they underwent CTCA and performed a standard treadmill exercise test. RESULTS: Eighty-nine patients aged 56.3+/-8.6 years were admitted. Eleven of them had selective angiography; CTCA identified all who had obstructive disease. More than half of the 85 patients who had normal values of cardiac troponin and of the 75 with a negative exercise test had radiological evidence of disease. During follow-up for 355+/-72 days none died, suffered myocardial infarction or required coronary artery surgery: two with obstructive disease underwent percutaneous coronary intervention 1 and 7 days after the index study. CONCLUSIONS: The CTCA findings were significantly correlated with those of selective angiography and with troponin status and increased the ascertainment of coronary artery disease in a cohort of patients at low risk for clinically significant ischaemic heart disease.

A mobile phone-based care model for outpatient cardiac rehabilitation: the care assessment platform (CAP).

BACKGROUND: Cardiac rehabilitation programs offer effective means to prevent recurrence of a cardiac event, but poor uptake of current programs have been reported globally. Home based models are considered as a feasible alternative to avoid various barriers related to care centre based programs. This paper sets out the study design for a clinical trial seeking to test the hypothesis that these programs can be better and more efficiently supported with novel Information and Communication Technologies (ICT). METHODS/DESIGN: We have integrated mobile phones and web services into a comprehensive home- based care model for outpatient cardiac rehabilitation. Mobile phones with a built-in accelerometer sensor are used to measure physical exercise and WellnessDiary software is used to collect information on patients' physiological risk factors and other health information. Video and teleconferencing are used for mentoring sessions aiming at behavioural modifications through goal setting. The mentors use web-portal to facilitate personal goal setting and to assess the progress of each patient in the program. Educational multimedia content are stored or transferred via messaging systems to the patients phone to be viewed on demand. We have designed a randomised controlled trial to compare the health outcomes and cost efficiency of the proposed model with a traditional community based rehabilitation program. The main outcome measure is adherence to physical exercise guidelines. DISCUSSION: The study will provide evidence on using mobile phones and web services for mentoring and self management in a home-based care model targeting sustainable behavioural modifications in cardiac rehabilitation patients. TRIAL REGISTRATION: The trial has been registered in the Australian New Zealand Clinical Trials Registry (ANZCTR) with number ACTRN12609000251224.

Comparison of abciximab with "high-dose" tirofiban in patients undergoing percutaneous coronary intervention.

BACKGROUND: The TARGET study has been criticised for sub-optimal platelet inhibition with tirofiban. We aimed to compare a high-dose bolus regimen of tirofiban (hd-tirofiban) to standard dose of abciximab for patients undergoing percutaneous coronary intervention (PCI). METHODS: We assessed consecutive patients who received either hd-tirofiban (25 mcg/kg bolus followed by 0.15 mcg/kg/min infusion for 18 h) or standard dose abciximab. In-hospital and 6-month outcomes were obtained in all cases. RESULTS: Over an 18-month period, 109 patients who received hd-tirofiban were compared with 110 patients who received abciximab. Both hd-tirofiban and abciximab groups had acute coronary syndromes in 86% and 80% and diabetes in 10% and 13% respectively. Most patients had coronary stent implantation (96% vs. 98%). Thrombocytopenia (platelet count< 100,000) developed in 0.9% of patients receiving hd-tirofiban and 2% of patients receiving abciximab (p = 0.566). Bleeding requiring transfusion occurred in 7.3% and 3% of patients respectively (p = 0.118). Peri-procedural troponin rise was 0.9% in patients receiving hd-tirofiban and 5.5% in patients receiving abciximab (p = 0.07). MACE (Myocardial infarction, Stroke, Revascularisation and Death) at 6 months was 23% in the hd-tirofiban group and 20% in the abciximab group (p = 0.711). The pharmaceutical costs were AUD 322 for hd-tirofiban (one ampoule) and AUD 1,350 for abciximab (3 ampoules). CONCLUSION: There was a small increase in bleeding requiring transfusion and a lower rate of peri-procedural troponin rise in the hd-tirofiban group however, the overall 6-month MACE rates were similar in both groups. There was a considerable cost-saving with the use of hd-tirofiban. A prospective randomised trial of hd-tirofiban vs. abciximab is warranted.

Measurement of myocardial fractional flow reserve is a cost-effective way to identify coronary artery lesions of indeterminate severity that warrant revascularisation.

BACKGROUND: The RADI pressure wire may be used in stenotic coronary arteries to calculate myocardial fractional flow reserve (FFR(myo)), the ratio between distal hyperaemic coronary pressure and aortic pressure. A ratio less than 0.75 categorizes lesions of haemodynamic significance for which percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) may be warranted. We undertook this study to evaluate the cost implications of performing these measurements. METHODS: We recorded FFR(myo) using RADI wires in 32 coronary artery lesions of between 30 and 60% diameter stenosis in 31 patients and assessed how this information changed our management. RESULTS: We followed our original "management plan" in only eight patients. PCI or CABG was performed in eight whose lesions were characterised by a FFR(myo) value of 0.76 or less. Myocardial perfusion imaging (MPI) was done in only one of nine for whom this had seemed to be appropriate. Two-thirds of those for whom PCI had appeared to be warranted were treated conservatively and only one quarter of the original "surgical" group underwent CABG. CONCLUSION: Although RADI pressure wires are an additional expense, it is appropriate to use them to assess coronary stenotic lesions of indeterminate severity. When we took into account the savings that arose from changes in management, the additional cost of measuring FFR(myo) was around dollar 580 per study.

Transthoracic left ventricular puncture for the assessment of patients with aortic and mitral valve prostheses: the Massachusetts General Hospital experience, 1989-2000.

Accurate assessment of suspected prosthetic valve dysfunction is critically important as reoperation carries high risk. Noninvasive methods of hemodynamic assessment of patients with both aortic and mitral mechanical valves continue to be frustrated by the interference created by prosthetic material and direct left ventricular puncture may be required for definitive hemodynamic assessment. We report the hemodynamic and angiographic results and outcomes of 38 consecutive patients with double valve replacement who underwent left ventricular puncture as part of evaluation of possible prosthetic dysfunction. These results were compared with those obtained by noninvasive testing. We found noninvasive assessment alone to be unsatisfactory as measurements of regurgitation and stenosis correlated poorly with those obtained by direct left ventricular puncture. Important information that altered patient management was obtained from invasive assessment in 68% of cases with an acceptable rate of complications. Therefore, hemodynamic and angiographic assessment using transthoracic left ventricular puncture should be entertained in patients with mitral and aortic valve replacement presenting with congestive heart failure and suspected prosthesis dysfunction.